Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of ACD856

Alzheimer Disease Clinical Trial

Official title:

A Prospective, Phase I, Double-blind, Parallel-group, Placebo-controlled, Randomised Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of ACD856 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077501
• Other study ID #: D2000CI-002
• Status: Completed
• Phase: Phase 1
• Start date: September 29, 2021
• Est. completion date: May 23, 2022

Study information

• Verified date: July 2022
• Source: AlzeCure Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The multiple ascending dose (MAD) design of the study is based on the aim to study safety, tolerability, PK and pharmacodynamics of selected doses of ACD856 in a limited number of healthy volunteers. ACD856 will be administered orally.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 23, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Signed and dated informed consent prior to any study-mandated procedure.
• Willing and able to comply with study requirements.
• Healthy male or female adults of non-childbearing potential aged = 18 and = 65 years at screening.
• Body mass index (BMI) = 18.0 and = 30.0 kg/m2 at screening.
• Only subjects of non-childbearing potential may be included in the study. Male subjects with partners of childbearing potential must be willing to use condoms, be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner, as well as refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.
• Clinically acceptable medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.

Exclusion Criteria:

• Any exposure to ACD856 in the past.
• Treatment with another investigational drug within 3 months prior to or during the study.
• Positive screen for drugs of abuse or a positive alcohol result at screening or admission to the clinic.
• Clinically relevant findings in laboratory parameters, ECG or vital signs at screening.
• Current smokers or subjects who use nicotine products.
• History of alcohol abuse or excessive intake of alcohol.
• History of, or current use of, anabolic steroids.
• Excessive caffeine consumption.
• Plasma donation or blood donation prior to screening.
• Any planned night shift work within the duration of the study, from 48 h prior to randomisation until follow-up.
• Any planned major surgery within the duration of the study.
• Evidence of an active infection that requires treatment with antibiotics within 2 weeks of planned dosing.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorder
• Cognition Disorders

Intervention

Drug:
• ACD856
Multiple daily oral doses of ACD856 will be administered for 7 days in an escalation scheme of dose 1, dose 2 and dose 3. The escalation schedule may be adapted based on evaluation by the internal Safety Review Committee.
• Placebo
Placebo oral solution

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AlzeCure Pharma

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of adverse events (AEs)	Number and percentage of subjects with adverse events (AEs).	16 days
Primary	Clinically significant changes in 12-lead ECGs	Number of subjects and percentage of subjects with clinically significant changes in 12-lead ECGs	16 days
Primary	Clinically significant changes in vital signs	Number of subjects and percentage of subjects with clinically significant changes in vital signs or stool frequency	16 days
Primary	Clinically significant changes in hematology, clinical chemistry, coagulation and/or urinalysis parameters	Number of subjects and percentage of subjects with clinically significant changes in any safety laboratory assessments.	16 days
Primary	Clinically significant changes in physical examinations	Number of subjects and percentage of subjects with clinically significant changes in physical examinations	16 days
Primary	GAD-7	Change from baseline of GAD-7	16 days
Primary	PHQ-9	Change from baseline of PHQ-9	16 days
Primary	C-SSRS	Change from baseline of C-SSRS	16 days
Primary	Prolactin	Change from baseline of prolactin levels	10 days